Lidar-Lite V3HP 21CFR 1040 Variance

Sensors Distance
1

I have some Lidar-Lite V3HP sensors installed in a system, and a customer is asking about the variance that is called out in the product data. It states “This product is in conformity with performance standards for laser products under 21 CFR 1040, except with respect to those characteristics authorized by Variance Number FDA-2016-V-2943 effective September 27, 2016.”

Can anyone help me find information on this specific variance?? In crunch time and garmin told me to come here…

~Phillip

2

Hi Phillip.

I’m sorry Garmin is giving you the runaround on this, they do that too a lot of customers.

Unfortunately SparkFun only resells these and we don’t actually make them or have access to this document. If Garmin isn’t able to provide it, you might try going through the Food and Drug Administration to see if they can help. I would imagine they could pull up a copy pretty quickly for you.